SOLICITATION NOTICE
A -- Clinical Trials Regulatory Affairs Director
- Notice Date
- 4/20/2004
- Notice Type
- Solicitation Notice
- NAICS
- 541618
— Other Management Consulting Services
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMC San Diego, Bldg 1 38400 Bob Wilson Drive, San Diego, CA, 92134-5000
- ZIP Code
- 92134-5000
- Solicitation Number
- N00259-04-T-0023
- Response Due
- 4/27/2004
- Archive Date
- 5/12/2004
- Point of Contact
- Laura Pruett, Purchasing Agent, Phone 619-532-8110, Fax 619-532-5596, - Loida Toledo, Supvy. Contract Specialist, Phone 619-532-5644, Fax 619-532-5596,
- E-Mail Address
-
lmpruett@nmcsd.med.navy.mil, lctoledo@nmcsd.med.navy.mil
- Small Business Set-Aside
- Total Small Business
- Description
- The proposed contract action is for supplies or services for which the Naval Medical Center San Diego intends to solicit with only one source, under the authority of FAR 6.302. Interested contractors / persons may identify their interest and capability to respond to the requirement or submit quotations. This notice of intent is not a request for competitive quotations. However, all quotes received April 27, 2004 @ 2:00 p.m. Pacific Standard time, will be considered by the Government. A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. This is a combined synopsis/solicitation for commercial items, prepared in accordance with the format in FAR subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes only solicitation, quotations are being requested and a written solicitation will not be issued. The solicitation number, N00259-04-T-0023 is issued as a request for quotation (RFQ). Clin 0001. 504 hrs @ $___=$___, Non-Personal Service Contract for a Clinical Trials Regulatory Affairs Director for the performance period of May 1, 2004 through July 31, 2004. Contractor shall perform in accordance with the attached Statement of Work. The services and duty hours will be perform at Naval Medical Center San Diego, Refractive Surgery Center Branch Medical Clinic, Bldg 624-2, 2650 Stockton Road, San Diego CA 92106. STATEMENT OF WORK Regulatory Affairs Director Ophthalmology Department PRK Program 1. SCOPE OF WORK This is a non-personal service contract for a Regulatory Affairs Director who provides senior level assistance as an investigator in support of refractive surgery trials requiring an Investigational Device Exemption (IDE) from the Food and Drug Administration (FDA). The primary work location is the Branch Medical Clinic, Naval Training Center San Diego. Secondary work locations are the Naval Medical Center San Diego (Balboa Hospital) and other clinical sites involved in collaborative research projects including Walter Reed Army Medical Center, Washington DC, and Wilford Hall Air Force Medical Center, San Antonio, TX. 2. DUTY HOURS The contractor shall be available for duty at the Naval Medical Center, San Diego, the Naval Training Center, San Diego, CA, or other clinical sites or locations as directed by the Director of Refractive Surgery from 0730-1630 (this includes a one-hour lunch), Monday through Friday. During periods of official travel, the contractor will be expected to work 8 hours per day. The contractor shall agree to modify these hours, as necessary, to ensure clinical and/or regulatory requirements are completed or deadlines met. This may require the contractor to work on weekends. An authorized WAWF acceptor from the refractive surgery center will verify work hours for travel and weekend work. If the contractor is required to work beyond the normal work hours or work weekends, the contractor will either be compensated with the normal hourly wage (no overtime) or commensurate leave at a later date to be mutually agreed upon. The contractor shall arrive for each scheduled shift in a well-rested condition and shall have had at least six hours of rest from all other duties immediately prior to reporting for the shift. The total number of working hours will be 504. Working hours will be verified by the Director or the Research Director, Refractive Surgery Center, Naval Medical Center San Diego. Invoices will be submitted biweekly. 3. DUTIES The contractor shall have primary responsibility to manage NMCSD refractive surgery IDE clinical trials designed to improve patient outcome. This includes providing direct patient care services for individuals enrolled in the clinical trials as well as monitoring compliance with Good Clinical Practices (GCP)?the standards for design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials?for IDE trials conducted under 21 CFR 81. Duties include patient vision testing, patient consent, providing information to patients in conformance with regulations (21 CFR 50), data collection and management systems based upon the requirements of 21 CFR 11 to ensure that electronic records and electronic signatures are trustworthy, reliable, and compatible with FDA's public health responsibilities. Further responsibilities will include: Conduct and audit clinical examinations to monitor data integrity and compliance with GCP, applicable government regulations and IRB requirements. Assist in the procurement of study funds, including drafting proposals, preparing interim reports, and liaison with study funding sponsors. Obtain informed consent from patients for participation in clinical trials. This includes extensive counseling patients as to the risks and benefits of their involvement. Assist in the preparation and execution of Cooperative Research and Development Agreements (CRADAs) and Memos of Understanding (MOUs). Develop, implement, and monitor a system to database study results which comply with 21 CFR 11 regarding electronic records in clinical trials. Assist in the preparation of technical abstracts and PowerPoint presentations. Assist in the preparation of protocols, IRB submission, case report forms, and subject consent documents. Liaison with FDA on protocol and reporting requirements. IDE preparation, submission, and reports. Provide guidance and support of clinical operations and patient education / testing procedures. The contractor may be required to travel up to 16 times a year. 4. SPECIAL REQUIREMENTS Must have BS in life sciences from an accredited university. Must have at least 5 years of clinical ophthalmic experience with direct patient care and be able to actively participate as an investigator, including creation and presentation of consent materials and performance of visual testing Must be willing and able to assist patient care services and provide educational information related to the diagnostic testing and visual performance protocols for laser refractive surgery procedures. Must have prior management experience, including creation of clinical procedures and patient instruction materials. Must have at least 15 years experience in the conduct and 10 years experience in the management of ophthalmic device clinical trials in conformance with FDA requirements and Good Clinical Practices Must be an active member of the ACRP (Association of Clinical Research Professionals) and RAPS (Regulatory Affairs Professional Society). Must have at least 5 years experience working with a major laser refractive surgery company and at least 3 years experience as a Director of Clinical/Regulatory Affairs in Class II/III ophthalmic devices. Must have experience with the development of Memos of Understanding (MOUs), with other military services. Must have current experience as an associate investigator in at least 2 IDE clinical trials conducted through a DoD medical treatment facility. Must have been involved in the creation and execution of at least three Cooperative Research and Development Agreements (CRADA) between a DoD facility and industry. Must have demonstrated success with ?Significant Risk? IDE trials to include direct experience interfacing with FDA/Ophthalmic Devices and division of Bioresearch Monitoring. Must be familiar with the principles of laser refractive surgery methods and wavefront technology, including current research and treatment issues. Must have strong experience writing protocols, consent forms, development of clinical database requirements, preparing data collection methods, initiating and monitoring clinical trials, designing training materials, writing interim and annual reports, planning and conducting investigator meetings, and interfacing with IRBs. Must be able to attend local / national / international ophthalmic meetings and meet with FDA. Must be able to communicate effectively, orally and in writing, using universal English. Must be proficient with computers and familiar with visual testing equipment and software for word processing, clinical data analysis and presentations, specifically Microsoft Office (Word, Excel, and PowerPoint). Must be proficient in a database management system which complies with 1 CFR 11 regarding electronic records in clinical trials. Specifically Study Builder, Study Builder, Inc. Payment Contractor must be CCR registeres and participate in the Wide Area Work Flow (WAWF) type payment process. All invoicing will be through electronic invoicing with certification of work performed by the government invoice acceptor then through the NMCSD Receipt Control and finally paid by EFT via DOD Finance and Accounting System The solicitation document and incorporated provisions and clauses are those in effect through FAC 2001-19. This acquisition incorporates the following FAR clauses: 52.212-1 Instruction to Offers- Commercial Item (JAN 2004) 52.204-7 Central Contractor Registration (Oct 2003) 52.212-3 Offeror Representations and Certification--Commercial Items , JAN 2004 52.212-4 Contract Terms and Conditions--Commercial Items OCT 2003 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, JAN 2004 52.217-8 Option to Extend Services (Nov 1999) 52.222-3 Convict Labor , JUN 2003 52.222-19 Child Labor -- Cooperation with Authorities and Remedies JAN 2004 52.222-21 Prohibition Of Segregated Facilities FEB 1999 52.222-26 Equal Opportunity, APR 2002 52.222-35 Equal Opportunity For Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans DEC 2001 52.222-36 Affirmative Action For Workers With Disabilities JUN 1998 52.222-37 Employment Reports On Special Disabled Veterans, Veterans Of The Vietnam Era, and Other Eligible Veterans DEC 2001 52.227-1 alt 1 Authorization & Consent (1995) alt 1 52.237-2 Protection Of Government Buildings, Equipment, And Vegetation APR 1984 52.252-2 Clauses Incorporated By Reference FEB 1998 252.204-7004 Alt A Required Central Contractor Registration Alternate A, NOV 2003 252.212-7001 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items DEC 2003 252.225-7002 Qualifying Country Sources As Subcontractors APR 2003 252.232-7003 Electronic Submission of Payment Requests DEC 2003 52.212-2, Evaluation ? Commercial Items (JAN 2004), the following factors shall be used to evaluate offers: 1) Past performance 2) Fully qualified and meeting all qualification on the statement of work (SOW). 3) Price. Past performance and qualification when combined has more importance than cost or price. Prior to Contract Award, the government reserves the right to review the resumes of contractor employees performing under the contract solely for the purpose of ascertaining their qualifications relative to the personnel qualifications terms of the contract. Accordingly, the contractor shall furnish such resumes and all professional requirements as stated in the Statement of Work (SOW) to the Purchasing Agent along with their quote. All responsible sources may submit a quote which shall be consideredto Laura Pruett, Naval Medical Center San Diego, Material Management Dept., Acquisitions Division, 34800 Bob Wilson Drive, San Diego, CA 92134, or by FAX (619) 532-5596 or by e-mail lmpruett@nmcas.med.navy.mil. This solicitation is restricted to small business. (Bids will be accepted from MOBIS or GSA Federal Supply Schedule Contract if applicable)
- Place of Performance
- Address: Naval Medical Center San Diego Refractive Surgery Center Branch Medical Clinic, 2650 Stockton Road, San Diego
- Zip Code: CA
- Country: USA
- Zip Code: CA
- Record
- SN00569507-W 20040422/040420212226 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |